Topical copper ion treatments and methods of treatment using topical copper ion treatments in the dermatological areas of the body

ABSTRACT

Copper ion treatments for dermatological areas of the body include solutions, creams, lotions, gets, foams, wound dressings, skin patches and suture material, each containing copper ions that bring about therapeutic effects when the copper ion treatments are applied to dermatological tissue. Methods of treating dermatological areas of the body include treatments for use on the skin and nails to treat conditions including disease, infection, inflammation, damaged or injured tissue, tissue needing to be sutured, rashes and other undesirable dermatological conditions.

This Application is a continuation of U.S. patent application Ser. No.13/842,387, filed on Mar. 15, 2013, and issued under U.S. Pat. No.10,398,733 on Sep. 3, 2019, the entire contents of which areincorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION Field of the Invention

The invention pertains generally to topical treatments containing copperions and to methods of treating body conditions using topical treatmentscontaining copper ions in various anatomical areas of the body. Moreparticularly, the invention pertains to treating body conditionsaffecting the dermatological areas using topical treatments containingcopper ions.

Brief Discussion of the Related Art

Many various abnormal body conditions are caused by harmful pathogens ormicrobes, examples of which include bacteria, fungi and viruses.Abnormal body conditions that arise in or affect the genital area inwomen typically affect the vagina and are commonly referred to as“vaginitis”. The term “vaginitis” encompasses infection and/orinflammation of the vagina caused by bacteria, fungi and/or viruses.Vaginitis may extend to the external female genital area, i.e. thevulva, in which case it is usually referred to as “vulvovaginitis”. Inaddition, bacterial, fungal and viral conditions that affect all or partof the genital area in women, i.e. vagina, vulva and/or surroundinganatomical area, may also affect all or part of the rectal (anal) area,i.e. the rectum (anal canal) and surrounding anatomical area. In men,infection and/or inflammation of bacterial, fungal and/or viral originsmay affect all or part of the rectal area and also all or part of thegenital area, i.e. the penis, scrotum and surrounding anatomical area.

Vaginitis that is bacterial in origin is commonly called “bacterialvaginosis”. Many different bacteria are responsible for bacterialvaginosis and some of these bacteria are the cause of sexuallytransmitted diseases in women and men. Examples of sexually transmittedbacterial diseases that affect the vagina and surrounding anatomicalareas are gonorrhea and chlamydia, which appear in the generalpopulation on a widespread basis. It is estimated by the Centers forDisease Control and Prevention (CDC) that more than 700,000 peopleannually in the U.S. alone acquire new gonorrhea infections, Accordingto the CDC, over 1.3 million chlamydia infections were recorded in theU.S. in 2010 alone. In addition, there are a large number ofundiagnosed, untreated or unreported infections of gonorrhea andchlamydia because the diseases may be asymptomatic or present with onlyvery mild symptoms. Oftentimes, gonorrhea and chlamydia occur together.Gonorrhea and chlamydia may also appear in the mouth, throat and rectum(anus) in men and women. If left untreated, gonorrhea and chlamydia canspread to the uterus and/or Fallopian tubes and may cause pelvicinflammatory disease (PID), ectopic pregnancies, chronic pelvic pain andincreased risk for infection with the human immunodeficiency virus(HIV). Untreated gonorrhea may also affect the blood, joints and heartvalves. The usual treatments for gonorrhea and chlamydia are appropriateantibiotics, but history has demonstrated that over time many bacterialdiseases develop a resistance to antibiotics, indeed, according to theCDC, numerous antibiotics previously used to treat gonorrhea have losttheir effectiveness, and there is currently only one remaining drug,i.e. the injectable antibiotic ceftriaxone, proven effective fortreating gonorrhea There is great concern in the medical community thatit is only a matter of time before gonorrhea becomes resistant to thislast remaining drug. Other types of pathogens and microbes, such as thebacteria streptococcus and staphylococcus and the parasitic protozoantrichomonas, may also affect the vagina and surrounding anatomical areasresulting in abnormal biological conditions. As with gonorrhea,staphylococcus infections are especially problematic because certainstrains of the bacteria have become antibiotic resistant. Infections inthe vagina may spread to the uterus, resulting in PID which is often avery painful and serious condition with potentially harmful andpermanent complications.

In addition to being susceptible to abnormal body conditions caused bybacteria, the vagina and surrounding anatomical areas are susceptible tovarious abnormal body conditions caused by viruses and fungi. Viraldiseases that arise in or affect the vagina and surrounding anatomicalareas include herpes (Types I and II), human papilloma virus (HPV) andHIV, all of which are sexually transmittable. Herpes, HPV and HIV canalso be found in the areas of the mouth, skin and rectum (anus). Fungaldiseases that arise in or affect the vagina include yeast infections,particularly Candida, and thrush. Fungi are also responsible forabnormal biological conditions in other areas of the body such as themouth (thrush), feet, skin and nails. There is no cure for herpes andHIV. Anti-viral drugs are available to alleviate herpes symptoms andsuppress the herpes virus so that active infections recur lessfrequently and are of shorter duration, but these drugs are associatedwith significant side effects. Infection with HPV is usually treatedwith topical medications, oral medications and/or surgical removal ofwarts. Complications of HPV infection include increased risk forcervical, rectal and vulvar cancers. Available treatments for HIV aredesigned to suppress the virus and boost the immune system in hope ofavoiding opportunistic infections and delaying or preventing the onsetof full-blown acquired immune deficiency syndrome (AIDS). In recentyears, it was hoped that a vaginal microbicide get called PRO 2000 wouldbe effective at reducing HIV infection when used shortly before sexualintercourse, but unfortunately the compound was found to be ineffectivein a large scale clinical trial. Topical and oral medications areavailable to treat yeast and other fungal infections, but are limited ineffectiveness such that fungal infections are often not eradicated andthus reoccur. The vast majority of abnormal body conditions caused bybacteria, viruses and fungi that affect the genital and/or rectal areasin women also affect the genital and/or rectal areas in men.

In addition to conditions caused by harmful pathogens or microbeshemorrhoids are another abnormal body condition that affects the rectum(anus) in men and women and may cause rectal pain, swelling, discomfortand/or itching. Conventional treatments for hemorrhoids include topicalmedications and surgery. In addition to harmful microbes and pathogens,sperm are microbes that appear in the vagina after intercourse. Numerousspermicidal contraceptive compounds are available for introduction inthe vagina. Typically, these must be introduced in the vagina veryshortly before intercourse and are therefore oftentimes inconvenient.When intercourse takes place without contraception and there is concernfor an unwanted pregnancy, drugs known as the “morning after pill” or“emergency contraceptives” are sometimes prescribed to preventpregnancy, but these drugs are not 100% effective and may haveundesirable side effects.

Abnormal body conditions of bacterial, viral and fungal origins commonlyarise in dermatological areas of the body, i.e. skin and nails. The skinand soft tissue are common sites for infections caused by variousbacteria including staphylococcus, enterobacter, pseudomonas, andstreptococcus. Oftentimes, infections develop on the skin at the site ofa cut, scratch, abrasion, burn, splinter, boil, pimple, blister, insectbite or other wound or trauma that damages or breaks the skin orprovides a point of entry for bacteria and/or other harmful organisms.Viruses such as herpes, shingles and HPV are also the cause of abnormalbody conditions on the skin. In particular, herpes causes cold sores(fever blisters), shingles causes painful eruptions, and HPV causeswarts on the skin. Other organisms also cause warts on the skin. Theskin is susceptible to various fungal conditions, such as “athlete'sfoot” which commonly occurs on the feet and rashes such as ringworm,infections of the nails, particularly fungal infections of the toenails,are also a common and tenacious problem. The skin is further susceptibleto various body conditions resulting from aging, environmental factorsand various external and internal causes, such conditions includingsun/wind damage, dry skin, age spots, pigmentation, scarring, blisters,boils, cysts, pimples, cuts, scratches, burns, abrasions, splinters,insect bites and stings, animal bites and scratches, ulcers, loss ofelasticity or collagen that manifests as wrinkles and sagging skin,acne, and many types of rashes, such as measles, chicken pox, eczema,psoriasis, impetigo and rosacea, due to various underlying external andinternal causes. Various topical and oral prescription andnon-prescription medications and products are available to treat theforegoing skin conditions, The skin is also a carrier for bacteria,viruses and fungi, seeing as how the skin regularly comes in contactwith a plethora of pathogens and microbes. Consequently, many productssuch as sanitizing hand and body lotions and wipes are availablecommercially for the purpose of reducing germs on the skin.

The oral-respiratory-otic areas of the body. i.e. mouth, throat, nose,sinuses and ears are also common sites for abnormal body conditions dueto the aforementioned pathogens and microbes. In addition, variousallergies cause undesirable body conditions that impact theoral-respiratory-otic areas of the body, particularly the throat, noseand sinuses. Asthma is a chronic inflammatory disease of the airwaysresponsible for undesirable conditions. Bacteria, viruses, fungi,allergies and/or asthma are responsible for many unwanted symptoms thatappear in the oral-respiratory-otic areas of the body including sorethroat, tonsillitis, colds, bronchitis, sinusitis, rhinosinusitis,wheezing, ear infections, earache, pressure in the ears, cold sores,mouth ulcers, canker sores, cough, hoarseness or laryngitis, congestion,runny nose, sneezing, sore gums, periodontal disease, tooth decay andhalitosis (bad breath). A vast array of prescription andnon-prescription drugs and products are commercially available to treatoral-respiratory-otic conditions.

The prescription drugs and even many of the non-prescription drugs orproducts used to treat the numerous body conditions described above havemany drawbacks including undesirable or potentially harmful sideeffects, high risk of harm in the event of overdose or improper use.high cost, limited effectiveness, the need for dose medical monitoring,and inconvenience. Moreover, there is presently no single compound orproduct to treat a wide range of body conditions affecting thegenital-rectal areas that include the vagina, rectum (anus), andsurrounding anatomical areas, the oral-respiratory-otic areas thatinclude the mouth, throat, airway, nose, sinuses and ears, and thedermatological areas that include the skin and nails, much less anon-pharmaceutical topical treatment that is safe, cost-effective, easyand convenient to use, and capable of being embodied in different formsdepending on the intended anatomical area or areas of use.

It has previously been established that copper possesses properties bywhich it is capable of killing, neutralizing and preventing the growthof human pathogens. It is known that many bacteria identified as humanpathogens cannot survive on surfaces of copper metal. U.S. Pat. No.8,135,468 82 to Fuller et al discloses a joint prosthesis having animplant body with an external surface containing an antimicrobial metalwhere the antimicrobial metal may be copper. U.S. Patent ApplicationPublications No. US 2012/0071807 A1 and No. US 2012/0089068 A1 toMcClure, Jr. disclose wound dressings containing a metal-basedantimicrobial agent where the metal-based antimicrobial agent may be amixture of silver ions and copper ions. Devices having an externalsurface of copper metal for insertion in the vagina to treat abnormalbiological conditions have been proposed by Applicants in U.S. patentapplications Ser. No. 12/157,823 filed Jun. 13, 2008 (abandoned), Ser.No. 13/317,230 filed Oct. 12,2011, and Ser. No. 13/464,005 filed May 4,2012, the entire disclosures of which are incorporated herein byreference.

Topical substances containing particles of copper or its alloys havebeen proposed for health support uses. A product called “MesoCopper®”sold by Purist Colloids, Inc. is a colloidal copper solution containingnano particles of copper for use on the skin to minimize the appearanceof fine lines and wrinkles. Another version of the product is sold as aningestible mineral supplement. Copper peptides for use on the skin arealso commercially available and these require peptides, i.e. smallfragments of protein that have an affinity for copper to which they bindvery tightly. U.S. Pat. No. 7776,315 B2 to Morariu discloses a topicalcomposition containing, at a minimum, a lipoic acid, a carnitine and acarnosine, where the carnosine may be chelated to zinc or copper ions.The intended use for the topical composition is to improve theappearance of aged skin. U.S. Patent Application Publication No.US2008/0195033 A1 to Eagleson et at discloses use of a metal substanceto treat diseases in the body. The metal substance is primarily acolloidal suspension and delivery of the substance to the body mayrequire the use of electricity. Prior to the present invention, it hasnot been recognized to provide a simple solution containing copper ionsfor use as a topical treatment to be applied directly to anatomicaltissue to treat body conditions and/or for use in conjunction withvarious carriers including creams, gels, lotions, foams, pastes, othersolutions, suppositories, tampons, body wipes, wound dressings, skinpatches and suture material to form topical treatments in which thecarriers facilitate delivery of the copper ions to contact anatomicaltissue depending on the anatomical area or areas of use on the body.

SUMMARY OF THE INVENTION

An aspect of the invention pertains to copper ion treatments for use ondermatological areas of the body including copper ion solutions, creams,lotions, gels, foams, body wipes, wound dressings, skin patches andsuture material, each containing copper ions that bring abouttherapeutic effects when the copper ion treatments are applied todermatological tissue. The copper ion solution includes a copperion-containing solution composed of a biocompatible solution and copperions contained in the biocompatible solution. The copper ion creams,lotions, gels and foams are composed of a base material and an amount ofthe copper ion-containing solution in the range of 5 percent to 30percent of the total weight of the copper ion creams, lotions, gels andfoams. The body wipes comprise a sheet or layer of material that carriesthe copper ion-containing solution. The wound dressings have aprotective surface for being positioned in contact with a damaged orinjured area of the skin, and the protective surface carries a copperion treatment, such as the copper ion-containing solution, such that thecopper ions are delivered to the damaged or injured area of the skin viacontact with the protective surface. The skin patches have a drugdelivery surface for being placed in contact with the skin, and the drugdelivery surface is supplied with a copper ion treatment such that thecopper ions are delivered to the skin. The suture material is suppliedwith a copper ion treatment, such as by being soaked or immersed in thecopper ion-containing solution. Then, when the suture material is usedto create sutures in anatomical tissue, the copper ions from the copperion treatment are delivered to the anatomical tissue.

Another aspect of the invention pertains to treating damaged or injuredareas of the skin by applying a copper ion treatment to the damaged orinjured area such that the copper ions contact the damaged or injuredarea and bring about therapeutic effects. Damaged or injured areas ofthe skin treatable with the copper ion treatments include wounds,blisters, boils, warts, cysts, pimples, cuts, internal or externalsurgical incisions, scratches, burns, ulcers, particularly leg and footulcers, abrasions, splinters, insect bites and stings, animal bites andscratches, sunburn and windburn. A damaged or injured area of the skinmay be treated by spraying the damaged or injured area with the copperion-containing solution, wiping the damaged or injured area with thecopper ion-containing solution using the body wipe, manually applying acopper ion cream, lotion, gel or foam to the damaged or injured area, orapplying the protective surface of the wound dressing to the damaged orinjured area. Where the damaged or injured area is a surgical incisionor a wound requiring sutures, the damaged or injured area can be treatedby using the copper ion suture material to create the sutures.

It is also an aspect of the invention to treat rashes on the skin byapplying a copper ion treatment to the rash on the skin such that copperions contact the area of the rash on the skin and bring abouttherapeutic effects. Rashes that may be treated using the copper iontreatments include eczema, psoriasis, rosacea, impetigo, ringworm, acneand heat rash. Rashes on the skin may be treated by spraying the copperion-containing solution on the rash, wiping the area of the rash withthe copper ion-containing solution using the body wipe, or manuallyapplying a copper ion cream, lotion, gel or foam to the area of the rashon the skin.

In accordance with another aspect of the invention, a copper iontreatment is applied directly to a cold sore or fever blister, such asthose that commonly occur on the lips. The copper ion cream, lotions orgels are well-suited for this purpose. When the copper ion treatment isapplied directly to a cold sore, the copper ions from the copper iontreatments bring about therapeutic effects directed at the cold sore.

The copper ion treatments are also used to improve the appearance of theskin, and the copper ion creams, lotions and gels are well-suited tothis purpose. In order to treat the facial skin for cosmetic purposesaccording to an additional aspect of the invention, the copper iontreatment is applied to the facial skin using the fingers and thetreatment is carried out on a regular basis. The copper ion treatmentmay also be applied to the skin on the neck. The therapeutic effectsprovided by the copper ions as a result of the copper ion treatmentbeing applied lo the skin on the face and/or neck bring aboutimprovement in the appearance of skin affected by wrinkles, sagging,undesirable pigmentation, age spots, dry skin, loss of collagen, andloss of skin tone.

An additional aspect of the invention involves using the copper iontreatment to sanitize areas of the skin. The copper ion-containingsolution and the copper ion lotions, gels, foams and body wipes areadvantageous for this purpose. When the copper ion treatment is appliedto an area of the skin to be sanitized, the copper ions bring aboutsanitizing effects on the skin including antiseptic, antibacterial,antiviral, antifungal anti-pathogenic and antimicrobial effects.

According to another aspect of the invention, “athlete's foot” istreated using a copper ion treatment. The copper ion creams and lotionsare well-suited for this treatment The treatment involves applying thecopper ion treatment to the area of one or both feet that is affected byathlete's foot, such that the copper ions from the copper ion treatmentcontact the affected area and bring about therapeutic effects directedat the athlete's foot infection.

The copper ion treatments are also used to treat nail fungus inaccordance with a further aspect of the invention. The copper ion creamsare well-suited for this use. Treatment of nail fungus using a copperion cream involves applying the copper ion cream to the affected nailand using the fingers to rub the copper ion cream into and around theaffected nail. The therapeutic effects resulting from the copper ions incontact with the infected nail, particularly the antifungal effect, arethus directed at the fungal infection affecting the nail.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front view of a bottle containing a copper ion treatment andhaving a spray pump nozzle for dispensing the copper ion treatment.

FIG. 2 is a side view of a bottle containing a copper ion treatment andhaving a spray pump nozzle with an elongate extension for dispensing thecopper ion treatment.

FIG. 3 is a side view of a bottle containing a copper ion treatmentwherein the bottle is squeezable to dispense the copper ion treatmentfrom a dropper on the bottle.

FIG. 4 is a side view of a bottle containing a copper ion treatment andhaving a brush for applying the copper ion treatment to anatomicaltissue.

FIG. 5 is a side view of a tube containing a copper ion treatmentwherein the tube is squeezable to dispense the copper ion treatment.

FIG. 6 is a side view of an alternative bottle that is squeezable todispense a copper ion treatment and showing the bottle in a dosedcondition.

FIG. 7 is a side view of the bottle of FIG. 6 showing the bottle in anopen condition.

FIG. 8 is a side view of a bottle containing a copper ion treatment andhaving a pump nozzle for dispensing the copper ion treatment in the formof foam.

FIG. 9 is a side view of an applicator for delivering a copper iontreatment to the vagina.

FIG. 10 is a side view of the applicator of FIG. 9 showing use of theapplicator in conjunction with the tube of FIG. 5 .

FIG. 11 is a side view of an alternative applicator for applying acopper ion treatment onto anatomical tissue.

FIG. 12 is a side view of a tampon having a tampon body used as acarrier to deliver a copper ion treatment to the vagina.

FIG. 13 is a broken front view of a plurality of suppositoriescontaining a copper ion treatment the suppositories being insertable inthe vagina or rectum to deliver the copper ion treatment to the vaginaor rectum.

FIG. 14 is a side view showing a suppository of FIG. 13 being removedfrom its package.

FIG. 15 is a side view of an applicator for delivering the suppositoriesof FIG. 13 to the vagina or rectum.

FIG. 16 is a front view of a package containing a body wipe carrying acopper ion treatment and showing the package partially open to removethe body wipe therefrom.

FIG. 17 is a perspective view of a wound dressing supplied with a copperion treatment.

FIG. 18 is a plan view of a skin patch carrying a copper ion treatment.

FIG. 19 is a perspective view of sutures created in anatomical tissueusing suture material carrying a copper ion treatment.

FIG. 20 is a broken top view of a dose of copper ion treatment in theform of lotion, cream, gel or foam dispensed onto the palm of a hand.

FIG. 21 is a broken side view of a dose of copper ion treatment in theform of lotion, cream gel or foam supported on the middle and indexfingers of a hand used to apply the copper ion treatment to anatomicaltissue.

DETAILED DESCRIPTION OF THE INVENTION

A solution containing copper ions, i.e. copper ion-containing solution,for use as a topical treatment containing copper ions, i.e. topicalcopper ion treatment, to treat body conditions is produced according toa process or method by which copper ions from copper metal are leachedinto an appropriate biocompatible solution. As used herein, “coppermetal” means pure copper (99.5% or greater copper after processing) andcopper alloys such as brasses, bronzes, copper-nickels andcopper-nickel-zincs. Preferably, pure copper is used as the coppermetal. Example 1 describes the steps involved in producing an amount ofcopper ion-containing solution equal or substantially equal to 7.44ounces.

Example 1

7.44 ounces of biocompatible saline solution buffered with acetic acidand sodium acetate to a pH of 5 (±0.4) is placed in a container orvessel with a tight, removable lid to minimize evaporation. Thecontainer is placed in an incubator or oven at a temperature of 37°Celsius (±1° C.). When the saline solution has reached 37° Celsius, 102grams of pure copper metal in solid form is placed in the heatedsolution within the container, and the container with the tight lidthereon is placed in the incubator at 37° Celsius for 24 hours. Duringthe 24 hour period, copper ions from the copper metal teach into thesolution. At the end of the 24 hour period, the container is removedfrom the incubator and the copper metal is removed or separated from thesolution. The amount of solution remaining after removal or separationof the copper metal therefrom constitutes the copper ion-containingsolution and should be essentially 7.44 ounces with minimal evaporation.The copper ion-containing solution produced according to this processcontains copper ions in an amount equal or substantially equal to 46milligrams when analyzed for copper content by inductively coupledplasma/optical emission spectroscopy (ICP/OES). The copperion-containing solution is stored at room temperature and is ready foruse in this form as a topical copper ion treatment to be applied toanatomical tissue to treat body conditions. In addition, the copperion-containing solution is ready for use in conjunction with variouscarriers including creams, gels, lotions, foams, pastes, othersolutions, suppositories, tampons, body wipes, wound dressings, skinpatches and suture material to form topical copper ion treatments inwhich the carriers facilitate delivery of the copper ion treatments tocontact anatomical tissue to treat body conditions.

The solid pure copper metal in Example 1 may be in the form of one ormore sheets of pure copper metal, typically in the range of 0.03 to 0.06inch thick, of appropriate length and width to provide the 102 grams ofpure copper metal. In practice, the process described in Example 1 hasbeen carried out using as the copper metal four vaginal therapeuticdevices made of pure copper in accordance with Applicants' prior U.S.patent application Ser. No. 13/464,005 previously incorporated herein byreference in its entirety. In this case, each vaginal therapeutic deviceused was 3.25 inches long by 0.750 inch wide with a wall thickness of0.031 inch providing 25.5 grams of pure copper. The biocompatible salinesolution used in the process described in Example 1 is commerciallyavailable from B. Braun Medical. As an alternative to the biocompatiblesaline, vaginal simulating fluid (VSF) buffered with acetic acid to a pHof 5 (±0.4) can be used as the biocompatible solution, but will produceless leaching of copper ions from copper metal over the 24 hour period.The VSF can be prepared in accordance with published literature, e.g.Owen, D. H., Katz. D. F., “A Vaginal Fluid Simulant”, Contraception,pages 91-95 (1999). The process described in Example 1 can be modifiedto eliminate the step of heating the solution prior to placement of thecopper metal therein. In the latter case, the copper metal and unhealedsolution are placed In the container, the container with the tight lidthereon is placed in the incubator at 37° Celsius and, once the solutionhas reached 37° Celsius, the container with the heated solution andcopper metal therein is allowed to remain in the oven for 24 hours. Thecopper metal can be removed or separated from the solution in variousways, such as by lifting the metal out of the solution or pouring thesolution alone into another container. Of course, the quantities ofbiocompatible saline and solid copper mental used in Example 1 can beproportionately increased to produce a greater amount of copperion-containing solution with each process.

The copper ion-containing solution is believed to have the greatesteffectiveness for treating a wide range of body conditions when thesolution contains the amount of copper ions leached into the saline fromthe copper metal over a 24 hour period as described in Example 1.However, it should be appreciated that the process described in Example1 can be modified to obtain lower copper ion concentrations by adjustingthe length of time that the container containing the heated saline andcopper metal is allowed to remain in the incubator or oven as explainedbelow in Examples 2, 3 and 4.

Example 2

Follow the steps of Example 1 but allow the container containing thesaline and copper metal to remain in the oven at 37° C. for one hour toobtain a copper ion-containing solution that contains an amount ofcopper ions equal or substantially equal to 8.8 mg.

Example 3

Follow the steps of Example 1 but allow the container containing thesaline and copper metal to remain in the even at 37° C. for eight hoursto obtain a copper ion-containing solution that contains an amount ofcopper ions equal or substantially equal to 22 mg.

Example 4

Follow the steps of Example 1 but allow the container containing thesaline and copper metal to remain in the oven at 37° C. for 72 hours toobtain a copper ion-containing solution that contains an amount ofcopper ions equal or substantially equal to 35 mg.

The copper ion-containing solution in its original form, i.e. at the endof the processes of Examples 1-4, can be applied directly to anatomicaltissue in various anatomical areas of the body as a copper ion treatmentto treat various body conditions. Many types of containers or bottlescan be used to hold a quantity of the copper ion-containing solution andto dispense or apply the copper ion-containing solution to anatomicaltissue in accordance with the intended anatomical area or areas of use.The copper ion-containing solution may also be used in conjunction withvarious carriers including creams, lotions, gels, foams, pastes, othersolutions, tampons, suppositories, body wipes, wound dressings such asband aids and pads, skin patches, and suture material to form copper iontreatments that facilitate delivery or application of the copperion-containing solution, and therefore the copper ions, to anatomicaltissue. Creams, lotions, gels, foams and pastes may be used when it isadvantageous to alter the consistency of the copper ion-containingsolution from its original form to obtain a thicker copper ion treatmentto facilitate its delivery or application to anatomical tissue. As aresult of the copper ions contacting anatomical tissue when the copperion treatments are applied thereto, local and systemic therapeuticeffects are realized including antibacterial, antimicrobial, antiseptic,antifungal, antiviral, anti-pathogenic, anti-inflammatory, spermicidal,neutralization of free radicals, promotion of healing and tissue repair,prevention of biofilm, and immune-boosting effects. In particular, theseeffects are realized when the copper ion treatments are used onanatomical tissue in the genital-rectal areas, the oral-respiratory-oticareas and the dermatological areas of the body since the anatomicaltissue in these areas is favorable for local and systemic delivery ofdrugs and medicaments.

In accordance with an aspect of the present invention, the copperion-containing solution is combined with an appropriate topical creambase to form a copper ion-containing cream, i.e. copper ion cream, inwhich the amount of copper ion-containing solution is preferably in therange of 5% to 30% by weight of the total weight of the copper ioncream. Examples 5, 6, 7 and 8 pertain to copper ion creams made inaccordance with this aspect of the invention using the copperion-containing solution of Example 1.

Example 5

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical cream base to form a copper ion cream in whichthe copper ion-containing solution constitutes 5 percent of the totalweight of the copper ion cream.

Example 6

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical cream base to form a copper ion cream in whichthe copper ion-containing solution constitutes 10 percent of the totalweight of the copper ion cream,

Example 7

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical cream base to form a copper ion cream in whichthe copper ion-containing solution constitutes 20 percent of the totalweight of the copper ion cream.

Example 8

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical cream base to form a copper ion cream in whichthe copper ion-containing solution constitutes 30 percent of the totalweight of the copper ion cream.

Various topical cream bases can be used as the carrier for the copperion-containing solution in order to form the copper ion creams ofExamples 5, 6, 7 and 8, One suitable topical cream base mat can be usedis VersaBase® cream made by Professional Compounding Centers of America(PCCA) of Houston, Tex. Another suitable topical cream base that can beused in the copper ion creams is Vanicream® made by PharmaceuticalSpecialties, Inc. of Rochester, Minn. The copper ion creams areeffective against the body conditions being treated when the only activeingredient in the copper ion creams directed at the underlying conditionis the copper ion-containing solution. However, the copper ion creamscould contain other ingredients added to the topical cream base that arenot active ingredients with respect to the underlying condition beingtreated such as preservatives, penetrating additives, bioadhesives andstability aids. Preferably, a total weight of at least 70 grams, morepreferably 80 grams, of the copper ion creams in the various strengths,i.e. 5 percent, 10 percent, 20 percent and 30 percent of copperion-containing solution relative to the total weight of the copper ioncream, will be provided for use in containers, bottles, or tubes fromwhich the copper ion creams can be dispensed. It should be appreciatedthat copper ion creams can be made using the alternative copperion-containing solutions described above.

According to a further aspect of the present invention, a topical copperion treatment in the form of a copper ion-containing gel, i.e. copperion gel, is composed of the copper ion-containing solution and asuitable topical gel base as illustrated below by Examples 9, 10, 11 and12, which utilize the copper ion-containing solution of Example 1, Theamount of the copper ion-containing solution in the copper ion gel ispreferably in the range of 5% to 30% by weight of the total weight ofthe copper ion gel.

Example 9

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical gel base to form a copper ion gel in which thecopper ion-containing solution constitutes 5 percent of the total weightof the copper ion gel.

Example 10

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical gel base to form a copper ion gel in which thecopper ion-containing solution constitutes 10 percent of the totalweight of the copper ion gel.

Example 11

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical gel base to form a copper ion gel in which thecopper ion-containing solution constitutes 20 percent of the totalweight of the copper ion gel.

Example 12

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical gel base to form a copper ion gel in which thecopper ion-containing solution constitutes 30 percent of the totalweight of the copper ion gel.

Various topical gel bases can be used as a carrier for the copperion-containing solution in order to form the copper ion gels. An exampleof a suitable topical gel base that can be used in Examples 9-12 isVersaBase® gel made by PCCA. As explained above for the copper ioncreams, the copper ion gels will be effective when the only activeingredient in the copper ion gels is the copper ion-containing solution,but other ingredients that are inactive with respect to the underlyingcondition being treated can be added to the topical cream gels.Preferably, a total weight of at least 70 grams, more preferably 80grams, of the copper ion gels in the various strengths, i.e. 5 percent,10 percent, 20 percent and 30 percent of copper ion-containing solutionrelative to the total weight of the copper ion gel, is provided for usein containers, bottles or tubes from which the copper ion gels can bedispensed. Also, copper ion gels can be made using the alternativecopper ion-containing solutions. Copper ion gels can be made having athin, fluidic consistency, and such gels may be used as copper ionserums.

A topical copper ion treatment in the form of a copper ion-containinglotion, i.e. copper ion lotion, according to an additional aspect of theinvention is composed of the copper ion-containing solution and asuitable topical lotion base as represented by Examples 13, 14, 15 and16. Examples 13-16 employ the copper ion-containing solution of Example1, but copper ion lotions could be made using the alternative copperion-containing solutions. The amount of the copper ion-containingsolution in the copper ion lotion is preferably in the range of 5% to30% by weight of the total weight of the copper ion lotion. Copper iongels can be made having a thin, fluidic consistency, and such gels maybe used as copper ion serums.

Example 13

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical lotion base to form a copper ion lotion in whichthe copper ion-containing solution constitutes 5 percent of the totalweight of the copper ion lotion.

Example 14

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical lotion base to form a copper ion lotion in whichthe copper ion-containing solution constitutes 10 percent of the totalweight of the copper ion lotion.

Example 15

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical lotion base to form a copper ion lotion in whichthe copper ion-containing solution constitutes 20 percent of the totalweight of the copper ion lotion.

Example 16

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical lotion base to form a copper ion lotion in whichthe copper ion-containing solution constitutes 30 percent of the totalweight of the copper ion lotion,

Various topical lotion bases can be used as a carrier for the copperion-containing solution in the copper ion lotions of Examples 13-16. Onesuitable topical lotion base that can be used is VersaBase® lotion madeby PCCA. As explained above for the copper ion creams and gels, thecopper ion lotions will be effective against the body conditions beingtreated when the only active ingredient in the copper ion lotions is thecopper ion-containing solution, but other inactive ingredients could beadded to the topical lotion base. Preferably, a total weight of at least70 grams, more preferably 80 grams, of the copper ion lotions in thevarious strengths, i.e. 5 percent, 10 percent, 20 percent and 30 percentof copper ion-containing solution relative to the total weight of thecopper ion lotion, will be provided for use in containers, bottles ortubes from which the copper ion lotions can be dispensed.

According to another aspect of the present invention, a topical copperion treatment in the form of a copper ion-containing foam, i.e. copperion foam, is composed of the copper ion-containing solution and asuitable foam base. Examples 17, 18, 19 and 20 set forth below pertainto copper ion foams or foamable solutions made in accordance with thisaspect of the invention using the copper ion-containing solution ofExample 1, however copper ion foams or foamable solutions can be madeusing the alternative copper ion-containing solutions. The amount of thecopper ion-containing solution in the copper ion foam or foamablesolution is preferably in the range of 5% to 30% by weight of the totalweight of the copper ion foam or foamable solution.

Example 17

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical foam base to form a copper ion foam or foamablesolution in which the copper ion-containing solution constitutes 5percent of the total weight of the copper ion foam or foamable solution.

Example 18

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical foam base to form a copper ion foam or foamablesolution in which the copper ion-containing solution constitutes 10percent of the total weight of the copper ion foam or foamable solution.

Example 19

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical foam base to form a copper ion foam or foamablesolution in which the copper ion-containing solution constitutes 20percent of the total weight of the copper ion foam or foamable solution.

Example 20

An appropriate amount of copper ion-containing solution is combined witha biocompatible topical foam base to form a copper ion foam or foamablesolution in which the copper ion-containing solution constitutes 30percent of the total weight of the copper ion foam or foamable solution.

Various topical foam bases can be used as a carrier for the copperion-containing solution in order to form the copper ion foams orfoamable solutions. Depending on the foam base used in Examples 17-20,the combination of foam base and copper ion-containing solution may bein the form of a foam. Alternatively, some foam bases that may be usedwill result in a foamable solution when combined with the copperion-containing solution, and the foamable solutions will typicallyrequire an appropriate dispenser to create the actual foam. An exampleof a suitable topical foam base that can be used is VersaBase® foam madeby PCCA. When using VersaBase® as the foam base in Examples 17-20, afoamable solution is obtained and requires a foam dispenser to createthe foam. As explained above for the copper ion creams, gels andlotions, the copper ion foams will be effective against the bodyconditions being treated with the only active ingredient therein beingthe copper ion-containing solution. However, other ingredients that areinactive with respect to the condition being treated can be added to thetopical foam base. It is preferred that a total weight of at least 70grams, more preferably 80 grams, of the copper ion foams or foamablesolutions in the various strengths, i.e. 5 percent, 10 percent, 20percent and 30 percent of copper ion-containing solution relative to thetotal weight of the copper ion foam or foamable solution, be provided indispensers from which the copper ion foams can be dispensed.

According to a further aspect of the invention, a topical copper iontreatment in the form of a copper ion-containing paste, i.e. copper ionpaste, is composed of the copper ion-containing solution and a suitablepaste base. Example 21 set forth below pertains to a copper iontoothpaste made in accordance with this aspect of the invention usingthe copper ion-containing solution of Example 1, but copper ion pastescan also be made using the alternative copper ion-containing solutions.The amount of the copper ion-containing solution in the copper ionpastes is preferably in the range of 5% to 30% by weight of the totalweight of the copper ion paste.

Example 21

An appropriate amount of copper ion-containing solution is combined witha toothpaste base material to form a copper ion toothpaste in which thecopper ion-containing solution constitutes in the range of 5 percent to30 percent of the total weight of the copper ion toothpaste.

The toothpaste base material used in Example 21 can be a commerciallyavailable toothpaste including any of the toothpastes marketed and soldunder the major brand names. A toothpaste made in accordance withExample 21 is advantageous for treating bad breath, sore gums, gumdisease and tooth decay when used on a daily basis in place of aperson's regular toothpaste.

According to a further aspect of the invention, the copperion-containing solution can be combined with various base solutions toform alternative copper ion solutions. Example 22 set forth belowpertains to a copper ion mouthwash made in accordance with this aspectof the invention using the copper ion-containing solution of Example 1,but copper ion solutions can also be made using the alternative copperion-containing solutions of Examples 2-4. The amount of copperion-containing solution in the alternative copper ion solution ispreferably in the range of 5% to 30% by weight of the total weight ofthe alternative copper ion solution.

Example 22

An appropriate amount of copper ion-containing solution is combined witha mouthwash base solution to form a copper ion mouthwash in which thecopper ion-containing solution constitutes in the range of 5 percent to30 percent of the total weight of the copper ion mouthwash.

The mouthwash base solution used in Example 22 can be a commerciallyavailable mouthwash including any of the mouthwashes marketed and soldunder the major brand names, A mouthwash made in accordance with Example22 is advantageous for treating bad breath, sore gums, periodontaldisease and tooth decay when used on a daily basis.

The examples described above pertaining to carriers in the nature oflotions, gels, foams and other solutions are particularly well suitedfor creating copper ion treatments in the nature of copper ion soaps byusing as carriers lotion, gel, foam or other solution bases containing asoap component. The copper ion soaps could be designed for use as bodysoaps or as dish soaps.

FIG. 1 depicts a device 10 useful for dispensing the copper iontreatments, particularly the copper ion-containing solutions in theiroriginal form, e.g. the form resulting from Examples 1-4, and the copperion lotions. The device 10 comprises a container or bottle 12 forholding the copper ion-containing solution and having a spray pumpnozzle 14 with an outlet orifice 16. The spray pump nozzle 14 isresiliency biased, typically by a spring, in an upward direction awayfrom the container 12 but is depressible in a downward direction towardthe container 12 to effect the spray pump action. Each time the spraypump nozzle is manually depressed the full amount, typically using afinger of the hand holding the container, a predictable amount of copperion-containing solution is discharged in the form of a spray or streamfrom the outlet orifice 16. The container 12 may include a removableprotective cover 18 for being disposed over the spray pump nozzle 14between uses. In use, the outlet orifice 16 is placed in line withanatomical tissue to be treated at a close enough distance that thetissue is within the range of the spray or stream dispensed from theoutlet orifice. The spray pump nozzle 14 is then depressed the fullamount using a finger, causing the predictable amount of copperion-containing solution to be delivered or sprayed onto the anatomicaltissue. The spray pump nozzle 14 can, of course, be depressed multipletimes to deliver multiple sprays or streams of the copper ion-containingsolution to the tissue. The device 10 is particularly useful fordispensing the copper ion-containing solution in its original form tocontact anatomical tissue within the mouth and throat, anatomical tissueof the skin, and anatomical tissue of the external genital and rectalareas. The device 10 could also be adapted to dispense the copper ionlotions, although in such case the copper ion lotions would typically bedispensed in the form of a ribbon, mass or stream of material. In thelatter case, the copper ion lotions could be dispensed directly on thetissue to be treated, or on the palm or fingers of a hand which is thenused to apply the lotions on the tissue to be treated. The copper ionlotions may be best suited for use on the skin, on the external genitaland rectal areas, and in the vagina.

Another device 20 useful for dispensing the copper ion treatments,particularly the copper ion-containing solution in its original form, isshown in FIG. 2 . The device 20 is similar to the device 10 andcomprises a container or bottle 22 having a spray pump nozzle 24 with anoutlet orifice 26. The device 20, however, further includes an elongatehollow extension 28 attached to the spray pump nozzle 24. The extension28 has a first end coupled with the outlet orifice 28 of the spray pumpnozzle 24 and has an opposed second end with a wider end surface havinga discharge opening 29. Preferably, a plurality of discharge openings 29are provided along the wider end surface as shown in dotted lines inFIG. 2 to obtain a wider spray pattern as indicated by dotted lines.Each time the spray pump nozzle 24 is manually depressed the fullamount, a predictable amount of copper ion treatment is released inspray form from the discharge openings 29 at the end of the extension28. The wider end surface arid plurality of discharge openings at thesecond end of the extension provides a wider spray pattern than thedevice 10. The device 20 could be designed without the spray pumpnozzle, with the container 22 being squeezable to force the copper iontreatment to be discharged from the discharge opening(s) 29. Theextension 28 may be selectively detachable/attachable to the spray pumpnozzle 24 for ease of storage of the device 20. The device 20 mayinclude a removable protective cover (not shown) for being placed overthe nozzle 24 between uses. The device 20 is particularly useful as anatomizer for dispensing the copper ion treatments to contact anatomicaltissue deeper within the mouth, throat and airway.

The device 30 depicted in FIG. 3 is also useful for dispensing thecopper ion treatments, particularly the copper ion-containing solutionin its original form. The device 30 comprises a squeezable container orbottle 32 for holding the copper ion treatment and having a tapereddropper or extension 34 with an outlet orifice 36 attached to a cap onthe container 32. In use, the container 32 is positioned so that theoutlet orifice 36, which is located at the tip of the dropper, facesanatomical tissue to be treated. The container 32 is then squeezed withthe fingers and, in response to such finger pressure, individual dropsof a predictable amount of copper ion treatment are released from theoutlet orifice 36. Alternatively, the extension 34 can be designed todischarge the copper ion treatment in the form of a spray as shown indotted lines in FIG. 3 , which would be particularly useful as anasal/ear spray. The tapered configuration of the dropper/extension 34facilitates its placement in the nostril (nasal cavity) and ear (earcanal). The container 32 may include a removable protective cover 38 forbeing disposed over the dropper 34 between uses. The device 30 isparticularly useful for dispensing the copper ion treatments to contactanatomical tissue within the nose (nostrils) and ears (ear canal), andon the skin and nails.

An additional device 40 for dispensing the copper ion treatments isshown in FIG. 4 . The device 40 comprises a container or bottler 42 forholding the copper ion treatment and having a removable cap 44 with abrush 45 attached to an underside of the cap. Typically, the cap 44 willbe screwed onto a neck of the container 42. When the cap 44 is disposedon the container 42, the brush 45 extends into the container and isdisposed within the copper ion treatment 43. Upon removal of the cap 44from the container 42, the cap 44 may be manipulated using the fingersand hand to contact anatomical tissue to be treated with the brush 45 inorder to deposit the copper ion treatment from the brush 45 onto theanatomical tissue. The device 40 would be particularly useful forapplying the copper ion treatments on the skin and nails. The brush 45could be eliminated from the cap 44, in which case the device 40, ifsized appropriately, would be advantageous for holding a copper ionsolution such as a copper ion mouthwash.

The device 50 illustrated in FIG. 5 is particularly useful fordispensing the copper ion treatments formed as creams, lotions, gels andpastes. The device 50 comprises a container 52 in the form of asqueezable tube for holding the copper ion treatment and having aremovable cap 54 disposed on an open end or neck 56 of the tube.Typically the cap 54 will be threaded onto an external thread 55 on theneck 56 of the tube. The cap 54 may optionally have a piercing formation57 that may be used to puncture an optional seal covering the open neck56 prior to the first use. Upon removal of the cap 54, the piercingformation 57 is placed against the seal, and the cap 54 is pushed in thedirection of the tube 52 to puncture the seal Once the seal ispenetrated, the tube 52 can be squeezed, preferably from the bottom ofthe tube working upward, causing the copper ten treatment to bedispensed from the open neck 58 of the tube. The device 50 isparticularly well suited for dispensing the copper ion treatments ontothe fingers or palm of a hand that is then used to apply the treatmentsto anatomical tissue, particularly the tissue of the skin and theexternal genital and rectal areas. However, the copper ion treatmentscould be squeezed directly on the anatomical tissue to be treated. Inaddition, when the copper ion treatment is in a paste or other suitableform for use as a toothpaste, the device 50 is particularly well suitedfor dispensing the copper ion treatment onto a tooth brush in aconventional manner. As explained further below, the device 50 isparticularly well suited for use with a vaginal applicator.

FIGS. 6 and 7 depict an additional device 60 useful for dispensing thecopper ion treatments. The device 60 is particularly advantageous fordispensing copper ion lotions. The device 80 comprises a container orbottle 82 for holding the copper ion treatment and having a cap 64disposed on an open end or neck of the bottle. The cap 64 could beremovable or non-removable. The top surface of the cap 64 is formed by apivotable member or disc 65 having an outlet orifice 66 along a sideedge thereof. FIG. 6 depicts the cap 64 in its closed condition whereinthe pivotable member 65 is in a horizontal position relative to the cap64 and the outlet orifice 66 is disposed within the cap 64 and is notexposed. When the pivotable member 66 is depressed downwardly toward thecontainer 62 at a location opposite the outlet orifice 66 as shown bythe arrow in FIG. 7 , the cap 64 will assume the open condition shown inFIG. 7 wherein the pivotable member 65 is disposed at an angle relativeto the cap 64 and the outlet orifice 66 is in an exposed positionlocated slightly above the cap 64. In use, the pivotable member 85 wouldbe depressed using pressure applied with one or more fingers of thehand. With the cap 64 in the open condition as shown in FIG. 7 , thecontainer 82 can be squeezed manually to dispense the copper iontreatment therein from the outlet orifice 86. The cap 64 is returned tothe closed position by pressing downwardly on the pivotable member 85 ata location adjacent the outlet orifice. The device 80 is advantageousfor dispensing the copper ion treatments onto the palm of the hand orfingers used to apply the treatment to anatomical tissue to be treated,but the device 80 could be used to dispense the copper ion treatmentsdirectly on the anatomical tissue to be treated.

The device 70 shown in FIG. 8 is an example of a device that can be usedto dispense the copper ion treatment in the form of a copper ion foam.The device 70 comprises a container 72 for holding the copper ion foamor foamable solution and having a resiliently biased foam pump dispenser74 with an outlet orifice 76. When the foam pump dispenser 74 isdepressed the full amount in a manner similar to the device 10, apredictable amount of the copper ion foam is discharged through theoutlet orifice 76. If necessary, the device 70 may include a mechanismfor creating foam as the copper ion treatment is discharged therefrom.The device 70 may have a removable protective cover 78 for beingdisposed over the foam pump dispenser 74 between uses. The device 70could also be adapted to dispense copper ion lotions and gels,

FIG. 9 depicts a vaginal applicator 81 useful for delivering the copperion treatments to the vagina. The vaginal applicator 81 is particularlyuseful in conjunction with the device 50 as depicted in FIG. 10 . Also,the vaginal applicator 81 is particularly well suited for use when thecopper ion treatments are in the form of either lotion, cream or gel.The vaginal applicator 81 comprises a hollow barrel 83 and a plunger 85slidably mounted in the hollow barrel 83. The barrel 83 has an openforward end defining a discharge opening 89 and has a rearward end wallthrough which a stem 91 of the plunger passes. The stem 91 is attachedat one end thereof to an internal flange 93 disposed within the barrelin close, sealing relation therewith. The plunger has a finger flange 95attached to an opposite end of the stem 91 that is disposed external ofthe barrel 83, the flange 95 being engageable with a finger or fingersof a hand in order to selectively depress and withdraw the plunger 85relative to the barrel 83. For use with the device 50, the forward endof the barrel 83 is provided with an internal thread 97 to threadedlyengage with the external thread 55 on the neck 58 of the tube 52.

FIG. 10 illustrates the vaginal applicator 81 being filled with thecopper ion treatment from the tube 52 of the device 50, As seen in FIG.10 , the cap 54 is removed from the neck 56 of the tube 52, and theforward end of the barrel 83 is threaded onto the neck 56 via threadedengagement of the threads 55 and 97. At this stage, the plunger 85 isfully withdrawn relative to the barrel 83 such that the internal flange93 is in abutment with the rearward end wall of the barrel 83. The tube52 is then squeezed using pressure from the fingers in order to dispensethe copper ion treatment, represented at 98, into the barrel 83 from theopen neck 56 of the tube 52. When the barrel 83 is sized for aparticular dosage of copper ion treatment, a sufficient amount of copperion treatment can be dispensed from the tube 52 to entirely fill thespace within the barrel 83 from the neck of the tube 58 to the internalflange 93 which is in abutment with the rearward end wall of the barrel.Alternatively, an indicia or other marking 99 can be provided on thebarrel 83 to indicate the point to which the barrel 83 should be filledwith copper ion treatment 98 from the tube 52. It is preferred thatfilling the space within the barrel from the neck of the tube to theinternal flange corresponds to a dose of 5 grams of the copper iontreatment. Once the barrel 83 has been filled with the appropriateamount of copper ion treatment 98, the barrel 83 is disengaged from theneck 58 of the tube 52 by disengaging the thread 97 from the thread 55.In order to dispense the copper ion treatment 98 from the applicator 81,the finger flange 95 of the plunger 85 is depressed toward the barrel 83using a finger, thereby causing the internal flange 93 to push thecopper ion treatment 98 through the discharge opening 89 as the plunger85 is depressed relative to the barrel 83. When the finger flange 95meets the rearward end wall of the barrel 83, the copper ion treatment98 will be fully discharged from the applicator. It should beappreciated that the applicator 81 could be used in conjunction withother devices for supplying the copper ion treatments to the barrel 85.It should also be appreciated that the applicator 81 can be supplied foruse pre-filled with copper ion treatment 98, in which case the forwardend of the barrel would be provided with a removable cap or seal. Theapplicator 81 is particularly advantageous for supplying the copper iontreatments to the vagina. Accordingly, prior to depressing the plunger85 to discharge the copper ion treatment 98 from the barrel 83, theforward end of the barrel 83 would be introduced into the vagina untilthe rearward end of the barrel was located near the entrance to thevagina. Then, upon depressing the plunger 85, the copper ion treatment98 is discharged from the discharge opening 89 into the vagina.

Another type of applicator useful in applying the copper ion treatmentsto anatomical tissue is shown at 101 in FIG. 11 . The applicator 101 isin the nature of a swab comprising a handle 103 and a body of absorbentmaterial 105 at an end of the handle 103. The applicator 101 can be usedin conjunction with a container or bottle containing a copper iontreatment, such as the device 40 of FIG. 4 . Upon removal of the cap 44from the bottle 42 of the device 40, the handle 103 of the applicator101 can be grasped with a hand used to manipulate the applicator 101 inorder to dip the body of absorbent material 105 into the copper iontreatment within the bottle 42. The body of absorbent material 105 canthen be gently contacted with anatomical tissue to be treated therebycausing the copper ion treatment carried by the absorbent body 105 to bedeposited on the anatomical tissue to be treated. The applicator 101 isbest suited for applying copper ion treatments to localized areas of theskin, nails, ear canal, nostrils, mouth and throat Of course, it shouldbe appreciated that swab applicators 101 can be provided in sealedpackages with the bodies of absorbent material 105 pre-supplied withcopper ion treatment.

Another type of carrier that can be used to deliver copper iontreatments to the vagina is a tampon. The tampon used can be acommercially available tampon or one similar thereto. The tampon can beone having an applicator including a barrel containing the absorbenttampon body and a plunger slidable within the barrel to dispose or ejectthe absorbent tampon body from an open forward end of the barrel oncethe forward end has been introduced in the vagina an appropriatedistance in a commonly known manner of tampon use. In this case, anappropriate amount of copper ion treatment can be supplied to theabsorbent tampon body via the open forward end of the barrel prior tointroduction of the applicator in the vagina and ejection of theabsorbent tampon body from the applicator into the vagina. Anothersuitable tampon can be one without an applicator, i.e. a digital tampon,where the absorbent tampon body is inserted in the vagina by pushing itwith the fingers. In this case, the appropriate amount of copper iontreatment is simply deposited on the absorbent tampon body prior to itsinsertion in the vagina. In both cases, unless the tampon is going to beinserted in the vagina immediately or soon after the absorbent tamponbody has been provided with the appropriate amount of copper iontreatment, the tampon should be stored in a sealed container or packageuntil the time of its use in order to avoid evaporation of the copperion treatment, it should be appreciated that tampon bodies to which thecopper ion treatment has been supplied can be provided in sealedcontainers or packages, with or without an applicator, as a ready-to-usecommercial product. Alternatively, the appropriate amount of copper iontreatment may be deposited by the user on the absorbent tampon bodies oftampons sold separately or in conjunction with the copper ion treatment.Preferably, the tampon bodies are supplied with an amount of copperion-containing solution in the range of 5 to 10 milliliters.

FIG. 12 illustrates a tampon 110 according to an aspect of the presentinvention including an applicator 111 having a hollow barrel 113 and ahollow plunger 115, and an absorbent tampon body 118, to which theappropriate amount of copper ion treatment has been supplied, disposedin the barrel 113 with the string 120 of the tampon body extending froma rear end of the plunger 115. The plunger 115 is slidable within andtoward the barrel 113 to push the tampon body 118 and eject it from anopen forward end 128 of the barrel. The forward end 128 of the barrel113 can be tapered to facilitate introduction and advancement in thevagina and can be provided with slits that expand as the tampon body 118passes therethrough. The tampon 110 is provided in an air-tightcontainer or bottle 122 having a removable cap or lid 124. In order touse the tampon 110, the lid 124 is removed from the bottle 122 and thetampon 110 is removed from the bottle. The tampon 110 is inserted in thevagina in a conventional manner of using tampons. More specifically, theapplicator 111 is held by grasping a finger grip 126 on the barrel 113,and the forward end 128 of the barrel is inserted in the vagina. Theapplicator 111 is advanced into the vagina until the fingers graspingthe finger grip 126 touch the entrance to the vagina. The plunger 115 isthen pushed into the barrel 113, thus causing the tampon body 118 to beejected from the forward end 128 of the barrel into the vagina. Theapplicator 111 is then withdrawn from the vagina and discarded, leavingthe tampon body 118 in place in the vagina. Once the tampon body 118 isin place in the vagina, the copper ion treatment carried by the tamponbody contacts the anatomical tissue of the vagina and leaks into thevaginal fluid normally present in the vagina. The tampon body 118 isremoved from the vagina at the appropriate time by grasping and pullingon the string 120. Examples of tampons according to an aspect of theinvention are described below in Examples 23 and 24.

Example 23

A tampon for delivering a copper ion treatment to the vagina is preparedby supplying 5 milliliters of a copper ion-containing solution to anabsorbent tampon body intended to be introduced into the vagina.

Example 24

A tampon for delivering a copper ion treatment to the vagina is preparedby supplying 10 milliliters of a copper ion-containing solution to anabsorbent tampon body intended to be introduced into the vagina.

The copper ion-containing solution used in Examples 23 and 24 is thecopper ion-containing solution in its original form as obtained inaccordance with the method set forth in Example 1. However, it should beappreciated that tampons can be provided in which the tampon bodies aresupplied with the alternative copper ion-containing solutions or otherforms of the copper ion treatments.

Another type of carrier useful to deliver the copper ion treatments tothe vagina and rectum is a suppository. Suppositories are commonly usedin the vagina and rectum (anus) as a means for dispensing various activeingredients or medicaments. Suppositories are made in various shapesincluding oviform, globular, conical and bullet shapes, and in varioussizes. Suppositories typically weigh in the range of 1 to 5 grams.Suppositories can be solid bodies composed of a mixture of a suitablesuppository base material and the active ingredients or medicaments.Alternatively, suppositories can be made with a solid outer wall ofsuppository base material enclosing non-solid active ingredients ormedicaments. The suppository base materials used in suppositories allowthem to dissolve or melt when exposed to the moisture (body fluid) orheat (body temperature) found in the vagina or rectum (rectal or analcanal), thereby releasing the active ingredients or medicaments into thevagina or rectum. Suitable suppository base materials include oleaginous(fatty) base materials, including cocoa butter, theobroma oil andsynthetic triglycerides, or water soluble or miscible base materials,including glycerinated gelatin and polyethylene glycol (PEG) polymers.It is preferred that the base materials be non-toxic, non-irritating,inert, and biocompatible. Suppositories suitable for use in an aspect ofthe present invention can be prepared in various ways according toconventional methods for preparing suppositories including compressionmolding and fusion molding. Suppositories for use as vaginal and rectalsuppositories according to an aspect of the present invention arepreferably made in two different sizes, i.e. a suppository weighing 3grams and a suppository weighing 5 grams, to accommodate different sizesof vaginal and rectal anatomy. Each size suppository can be made indifferent strengths based on the percentage by weight of the activeingredient, i.e. the copper ion treatment, relative to the total weightof the suppository. Preferably, the amount of copper ion-containingsolution in the suppository is in the range of 5% to 30% of the totalweight of the suppository. The suppositories are preferably formed inplastic molds and can be stored at room temperature. The suppositorieswill be effective against the body condition being treated when the onlyactive ingredient contained in the vaginal and rectal suppositories isthe copper ion treatment. However, the vaginal and rectal suppositoriescould contain additional ingredients that are inactive with respect tothe underlying condition or conditions being treated, such aspreservatives, penetrating additives, bioadhesives and stability aids.The suppositories may be inserted in the vagina and rectum using thefingers, or the suppositories may be provided with applicators tofacilitate insertion thereof in the vagina and rectum. Examples ofvaginal and rectal suppositories according to an aspect of the inventionare set forth in Examples 25-32, which utilize the copper ion-containingsolution of Example 1. However, the alternative copper ion-containingsolutions could be used in Examples 25-32.

Example 25

A suppository base material is combined with an appropriate amount ofcopper ion-containing solution and is molded into a suppository forvaginal or rectal use having a total weight of 3 grams, wherein thecopper ion-containing solution constitutes 5 percent of the total weightof the suppository.

Example 26

A suppository base material is combined with an appropriate amount ofcopper ion-containing solution and is molded into a suppository forvaginal or rectal use having a total weight of 3 grams, wherein thecopper ion-containing solution constitutes 10 percent of the totalweight of the suppository.

Example 27

A suppository base material is combined with an appropriate amount ofcopper ion-containing solution and is molded into a suppository forvaginal or rectal use having a total weight of 3 grams, wherein thecopper ion-containing solution constitutes 20 percent of the totalweight of the suppository.

Example 28

A suppository base material is combined with an appropriate amount ofcopper ion-containing solution and is molded into a suppository forvaginal or rectal use having a total weight of 3 grams, wherein thecopper ion-containing solution constitutes 30 percent of the totalweight of the suppository.

Example 29

A suppository base material is combined with an appropriate amount ofcopper ion-containing solution and is molded into a suppository forvaginal or rectal use having a total weight of 5 grams, wherein thecopper ion-containing solution constitutes 5 percent of the total weightof the suppository.

Example 30

A suppository base material is combined with an appropriate amount ofcopper ion-containing solution and is molded into a suppository forvaginal or rectal use having a total weight of 5 grams, wherein thecopper ion-containing solution constitutes 10 percent of the totalweight of the suppository.

Example 31

A suppository base material is combined with an appropriate amount ofcopper ion-containing solution and is molded into a suppository forvaginal or rectal use having a total weight of 5 grams, wherein thecopper ion-containing solution constitutes 20 percent of the totalweight of the suppository.

Example 32

A suppository base material is combined with an appropriate amount ofcopper ion-containing solution and is molded into a suppository forvaginal or rectal use having a total weight of 5 grams, wherein thecopper ion-containing solution constitutes 30 percent of the totalweight of the suppository.

FIG. 13 illustrates a strip 131 of interconnected packages or pods 132,each enclosing a vaginal or rectal suppository 130 containing a copperion treatment. The pods 132 are separated from each other by aperforation fine 133 allowing the pods 132 to be detached from eachother by tearing along the perforation fines 133 as depicted in FIG. 13. Each pod 132 has front and rear walls 135 between which a suppository130 is retained. The front and rear waifs 135 are sealed to one anotheralong their peripheral edges. As shown in FIG. 14 , each pod 132 isprovided with a pair of finger tabs 134 respectively attached to thefront and rear walls 135, the finger tabs 134 being capable of beingpulled in opposite directions using the fingers to separate the opposedwaits 135 and thereby release the suppository 130 contained therein.

FIG. 15 illustrates an applicator 181 suitable for use in delivering asuppository 130 to the vagina or rectum. The applicator 181 is similarto the applicator 81 but does not have an internal thread at the forwardend of the barrel 183. in addition, the plunger 185 of the applicator181 has two internal flanges 193 a and 193 b within the barrel 183, theflange 193 a controlling the distance that the plunger can be withdrawnrelative to the barrel and the flange 193 b serving to eject thesuppository from the barrel when the plunger is depressed the fullamount. In use, a suppository 130 is manually positioned in the openforward end of the barrel 183 as illustrated in FIG. 15 . The openforward end of the barrel 183 is preferably sized to retain thesuppository 130 in position without being overly snug or tight. Theplunger 185 is withdrawn the full amount relative to the barrel 183,which coincides with abutment of internal flange 183 a with the rearwardend wall of the barrel 183. The forward end of the barrel 183 holdingthe suppository is then introduced in the vagina or rectal (anal) canal,and the applicator 181 is gently pushed into the vagina or rectal canaluntil the fingers holding the rearward end of the barrel 183 areadjacent or touch the entrance to the vagina or rectal canal. The fingerflange 195 is then depressed to push the plunger 185 toward and into thebarrel 183 as shown by the arrow in FIG. 15 , thus causing the flange193 b to engage the suppository 130 and eject it from the forward end ofthe barrel into the vagina or rectal canal. The applicator 181 is thenremoved from the vagina or rectal canal, leaving the suppository in thevagina or rectal canal. The suppository will melt or dissolve in thevagina or rectal canal such that the copper ion treatment is released tocontact anatomical tissue of the vagina or rectal canal and to minglewith body fluid present in the vagina or rectal canal. Another type ofcarrier that can be used to deliver the copper ion treatments toanatomical tissue is a body wipe. FIG. 16 illustrates a body wipe 200contained in a sealed package 202 having front and rear walls 203. Thebody wipe 200 comprises a thin sheet of material disposed in a foldedcondition when retained between the front and rear walls 203, which aresealed along their peripheral edges. The body wipe 200 enclosed betweenthe front and rear walls 203 contains a wet or moist copper iontreatment. The front and rear walls 203 may be grasped by the fingers atcorresponding corners thereof and pulled in opposite directions similarto the pods 132 in order to separate the front and rear walls 203 andthereby allow the body wipe 200 to be removed from the package 202. FIG.16 shows the package 202 in a partially open condition in whichcorresponding corner sections of the front and rear walls 203 have beenpeeled away from one another thereby providing access to the body wipe200. Upon removal from the package 202, the body wipe 200 can beunfolded to its full size, which is substantially larger than its sizein the folded condition, and can be used to wipe anatomical tissue to betreated causing the copper ion treatment to be transferred to theanatomical tissue. The body wipe 200 is advantageous for applying thecopper ion treatments to the skin and the external genital and rectalareas.

Another type of carrier for the copper ion treatments is a wounddressing, such as a band aid, gauze pad or similar device. Such earnerscan be selected from products that are commercially available forremovable application to the skin to temporarily cover and protect anaffected area of the skin. FIG. 17 depicts a carrier in the nature of awound dressing 300 having a surface 301 for being placed in contact withthe skin. The surface 301 includes a protective surface 302 for beingpositioned over a wound, and an adhesive border surrounding the surface302. In use, a copper ion treatment, such as the copper ion-containingsolution in original form, can be liberally sprayed onto the surface 302of the carrier that is applied adjacent or in contact with the skin.Then, when the surface 302 of the carrier is applied adjacent or incontact with the skin and the carrier is left in place on the skin for aperiod of time, the copper ions contact or are transferred to the skinand provide the therapeutic effects described above. Of course, it wouldbe possible to provide carriers of this type in sealed packages in whichthe carriers are pre-supplied or pre-treated with the copper iontreatment similar to the body wipe 200.

A further type of carrier for the copper ion treatments is a skin patch,such as a dermal patch or a transdermal patch, represented at 400 inFIG. 18 . The skin patch 400 has a drug delivery surface 401 containingthe copper ion treatment surrounded by an adhesive border 402. The patchis applied to the skin and left in place for a period of time with thedrug delivery surface in contact with the skin, causing the copper ionsto diffuse through the skin where they can act locally or penetrate thecapillaries for broader systemic effects. Examples of suitabletransdermal patches are the transdermal and microneedle 3M Drug DeliverySystems manufactured by 3M Corporation.

An additional type of carrier for the copper ion treatments is suturematerial, represented at 500 in FIG. 19 , used by medical professionalsto close or suture external or internal incisions or wounds, i.e.“stitches.” Prior to using the suture material 500, which can beconventional suture material, the suture material can be soaked in thecopper ion-containing solution for a period of time in order to cover orsaturate the suture material with the solution. Suture material can alsobe stored in sealed packages containing the copper ion-containingsolution. Then, when the suture material 500 is used to create suturesor stitches in anatomical tissue T as seen in FIG. 19 , the copper ionsin the solution contact the anatomical tissue and provide thetherapeutic effects previously described.

The copper ion-containing solution and the other forms of copper iontreatments described herein can be used on anatomical tissue in variousareas of the body including the genital-rectal areas (vagina, vulva,penis, scrotum, rectum (anus), rectal (anal) canal and surroundinganatomical areas), the oral-respiratory-otic areas (mouth, throat,airway, nostrils and ears) and the dermatological areas (skin and nails)of the body. The treatment effects provided by the copper ion treatmentsencompass treatment of active or existing disease and other undesirablebody conditions as well as the prevention of such diseases andconditions. The copper ion treatments are especially beneficial fortheir ability to kill or neutralize harmful or undesired pathogens andmicrobes including bacteria, viruses and fungi. Although the copper iontreatments are applied topically to anatomical tissue and have alocalized effect on diseases and undesirable body conditions affectingthe anatomical tissue, the copper ion treatments also have a broadersystemic effect on diseases and undesirable body conditions. The effectsrealized with the copper ion treatments include antibacterial,antimicrobial, antiseptic, antifungal, antiviral, anti-pathogenic,anti-inflammatory, spermicidal, neutralization of free radicals,promotion of healing and tissue repair, prevention of biofilm, andimmune-boosting effects. The diseases or conditions affecting thegenital-rectal areas that are treatable with the copper ion treatmentsinclude vaginitis, bacterial vaginosis, hemorrhoids, vaginal dryness,imbalances in vaginal pH, bacterial infections caused by gonorrhea,chlamydia, streptococcus and staphylococcus, protozoan infections causedby trichomonas, pelvic inflammatory disease, viral infections caused byherpes (I and II), HPV and HIV, fungal infections caused by yeast,Candida, thrush and other fungi, exposure to sexually transmitteddiseases, and the risk of undesired pregnancy (contraception). Thediseases or conditions affecting the oral-respiratory-otic areas thatare treatable with the copper ion treatments include bacterialinfections caused by gonorrhea, chlamydia, streptococcus andstaphylococcus, protozoan infections caused by trichomonas, viralinfections caused by herpes (I and II), HPV and HIV, canker sores, mouthsores, mouth ulcers, colds, sinusitis, rhinosinusitis. sore throat,nasal discharge, congestion, runny nose, bronchitis, allergies, asthma,tonsillitis, wheezing, sneezing, ear infections, earache, pressure inthe ears, cough, hoarseness, laryngitis, sore gums, periodontal disease,bad breath and tooth decay. The diseases or conditions affecting thedermatological areas that are treatable with the copper ion treatmentsinclude bacterial infections caused by staphylococcus, streptococcus,enterobacter, e. coli and pseudomonas, viral infections caused byshingles, herpes (I and II) and HPV, fungal infections such as athlete'sfoot, ringworm and toenail fungus, impetigo, rosacea, psoriasis, eczema,warts, sun/wind damage, dry skin, age spots, pigmentation, scarring,blisters, boils, cysts, pimples, cuts, scratches, burns, abrasions,splinters, insect bites and stings, animal bites and scratches, ulcers,loss of elasticity or collagen, wrinkles, sagging skin, acne, measles,chicken pox, and the presence of pathogens and microbes on the skin thatis an inevitable consequence of daily life. Based on the result oflaboratory testing, it is expected that the copper ion treatments willkill bacteria causing bacterial vaginosis, gonorrhea and chlamydia, andthe viruses responsible for Herpes (I and II) and HIV at a kill rate of99.99 percent in 6 hours. Accordingly, the copper ion treatments aresufficiently effective to “cure” the diseases and conditions describedherein and to prevent the occurrence or development of such diseases andconditions. Similarly, copper has been demonstrated as having thecapability to kill or render inactive staphylococcus, streptococcus,enterobacter, trichomonas, E. coli and pseudomonas. The copper iontreatments are highly effective at treating the various abnormal orundesired body conditions while being safe and non-toxic. In particular,copper toxicity is so rare that the World Health Organization (WHO) hasdetermined that there is no need for setting an upper threshold for theingestion of copper. The copper ion treatments can thus be safely usedwithout concern for overdosing or improper use. Moreover, it is believedthat, to date, no bacteria or other harmful microorganisms have beenfound to be capable of developing a resistance to copper, in contrast tothe many bacteria and organisms that have developed or are in theprocess of developing resistance to conventional antibiotics. Themulti-target effects of copper makes bacterial resistance extremelyunlikely as copper kills bacteria very quickly and leaves almost nosurvivors. Consequently, there is neither the time for bacteria to“learn” how to resist the killing effect of copper or the possibility topass on any knowledge to a significant population of survivors. Thecopper ion treatments provide a degree of efficacy and safety fortreating a wide array of diseases and body conditions that far surpassesconventional pharmaceutical and non-pharmaceutical products and drugsavailable for treating the same conditions.

When using a copper ion treatment on the skin or nails in the form ofcopper ion lotion, cream, gel or foam, the copper ion treatment willtypically be topically applied to the skin or nails using one or morefingers of a hand as represented in FIGS. 20 and 21 . FIG. 20 shows adose of copper ion treatment 98 in the form of copper ion lotion, cream,gel or foam deposited on the palm P of a hand H. The dose is a dollop ofcopper ion lotion, cream, gel or foam in the approximate size of anickel or quarter, but larger doses of copper ion treatment can be usedin accordance with the size of the area on the skin to be treated. Thedose can be delivered or deposited onto the palm P of the hand H from adevice such as the devices 10, 50, 60 and 70 previously described above.The fingers F of the opposite hand may be used to “scoop” the dollop ofcopper ion treatment from the palm P, as seen in FIG. 21 which shows thedose of copper ion treatment 98 now deposited on the index and middlefingers F of the opposite hand H. Alternatively, the copper iontreatment can be dispensed or deposited directly onto one or morefingers F of the hand. Using one or more fingers F, the copper iontreatment 98 can be applied to anatomical tissue of the skin or nailsand gently rubbed into the tissue.

According to an aspect of the invention, damaged or injured areas of theskin are treated by applying a topical copper ion treatment to theaffected area of the skin as described below in Examples 33-37. Themethods of Examples 33-37 are particularly advantageous for treatingareas of the skin damaged or injured due to conditions including wounds,blisters, boils, warts, cysts, pimples, cuts, scratches, burns, sunburn,windburn, abrasions, splinters, foot and leg ulcers, insect bites orstings, animal bites or scratches, surgical incisions, and conditionscreating breaks in the skin that provide an opportunity for the entry ofpathogens and microbes. The methods of Examples 33-37 are particularlybeneficial for treating active infection or inflammation in damaged orinjured areas of the skin, for preventing or reducing the risk ofinfection or inflammation in damaged areas of the skin, promotinghealing of damaged or injured areas of the skin and relieving discomfortor pain arising from damaged or injured areas of the skin. Examples 33,34 and 35 describe methods that involve applying the copperion-containing solution in original form to the skin. Examples 33, 34and 35 utilize the copper ion-containing solution of Example 1, but thealternative copper ion-containing solutions of Examples 2-4 could beused. Example 33 is best carried out using the device 10 of FIG. 1 tospray the copper ion-containing solution on the skin. Example 34 can becarried out using the body wipe 200 of FIG. 16 or the swab 105 of FIG.11 . Example 35 is carried out using suture material 500 to apply thecopper ion-containing solution, where the suture material 500 has beensoaked in the copper ion-containing solution. Accordingly, the method ofExample 35 applies to external or internal surgical incisions or woundsthat require stitches or suturing.

Example 33

As soon as possible following damage or injury to an area of the skin,liberally spray the damaged or injured area of the skin with the copperion-containing solution using several consecutive pumps of the spraypump nozzle 14. Allow the area of the skin to air dry. Repeat every fourhours until the damaged or injured area of the skin has healed.

Example 34

As soon as possible following damage or injury to an area of the skin,gently wipe the damaged or injured area of the skin with the body wipe200 carrying the copper ion-containing solution, or gently swab thedamaged or injured area of the skin with the swab 105 carrying thecopper ion-containing solution, to deposit a liberal amount of thecopper ion-containing solution on the affected area of the skin. Allowthe area of the skin to air dry. Repeat every four hours until thedamaged or injured area of the skin has healed.

Example 35

In order to create stitches or sutures in open wounds or surgicalincisions in anatomical tissue, stitch or suture the anatomical tissueusing suture material that has been soaked or immersed in the copperion-containing solution for 30 minutes.

The method of Example 36 involves applying a copper ion cream, gel,lotion or foam to the damaged or injured area of the skin, where thecopper ion cream, gel, lotion or foam contains an amount of the copperion-containing solution in the range of 5 percent to 30 percent of thetotal weight of the copper Son cream, gel, lotion or foam as describedabove in Examples 5-20, The method of Example 36 may be carried outusing the device 50 to dispense the copper ion creams and gels, thedevice 60 to dispense the copper ion lotion, and the device 70 todispense the copper ion foam. The copper ion cream, gel, lotion or foamcan be dispensed from the corresponding device directly onto theaffected area of skin but, more typically, the copper ion cream, gel,lotion or foam will be dispensed from the corresponding device onto thehand and applied to the affected area using one or more fingers asdescribed above and illustrated in FIGS. 20 and 21 .

Example 36

As soon as possible following damage or injury to an area of the skin,liberally apply a copper ion treatment in the form of copper ion cream,gel, lotion or foam to the damaged or injured area of the skin. Gentlypat, rub or smooth the copper ion treatment into the affected area ofthe skin. Repeat every four hours until the damaged or injured area ofthe skin has healed.

When carrying out the methods of Examples 33, 34 and 36, and whencarrying out the method of Example 35 to form external stitches orsutures, a protective wound dressing or pad can be placed over theaffected area of the skin after the application of the copper iontreatment thereto. When using the method of Example 36 to treat foot orleg ulcers, the affected area of the leg or foot should be covered withgauze, which can be held in place using tape.

The method of Example 37 involves use of a wound dressing to deliver orapply the copper ion treatment to the damaged or injured area of theskin. In particular, Example 37 employs a wound dressing 300 having aprotective surface 301 to be placed in contact with or adjacent thedamaged or injured area of the skin, in which the surface 301 has beensupplied with copper ion treatment, such as the copper ion-containingsolution, as previously described above. The wound dressing 300 would beheld or secured in place on the skin by means of the adhesive border302.

Example 37

As soon as possible following damage or injury to an area of the skin,position a protective surface of a wound dressing that has been suppliedwith a copper ion treatment over the damaged or injured area of the skinwith the surface adjacent or in contact with the damaged or injured areaof the skin. Secure the wound dressing in place on the skin and allowthe wound dressing to remain in place for four hours. Remove the wounddressing from the skin after it has been allowed to remain in place onthe skin for four hours, and repeat the method using a new wounddressing supplied with the copper ion treatment. Continue to repeatevery four hours until the damaged or injured area of the skin hashealed.

The method of Example 37 can be modified to use the skin patch 400 inplace of the wound dressing, and normally the skin patch would be placedon healthy, undamaged skin and would be left in place on the skin for aconsiderably longer period of time. As a result of the copper tons fromthe copper ion treatment contacting the anatomical tissue in the methodsof Examples 33-37, the local and systemic therapeutic effects aspreviously described above are realized.

Another aspect of the invention involves treating rashes on the skinusing a copper ion treatment as explained below in Examples 38-40. Themethods of Examples 38-40 are particularly advantageous for treatingrashes arising from conditions including one or more of eczema,psoriasis, rosacea, acne, impetigo, chicken pox, measles, shingles,ringworm and herpes. The method of Example 38 utilizes the copperion-containing solution of Example 1; however, the copper ion-containingsolutions of Examples 2-4 could be utilized. The method of Example 38can be carried out using the device 10 of FIG. 1 to spray the copperion-containing solution on the affected area of the skin. The method ofExample 39 may be carried out using the body wipe 200 of FIG. 16 .

Example 38

As soon as possible following diagnosis or the onset of a rash on theskin, liberally spray the area of the rash on the skin with the copperion-containing solution using several consecutive pumps of the spraypump nozzle 14. Allow the area of the skin to air dry. Repeat every fourhours until the rash has disappeared.

Example 39

As soon as possible following diagnosis or the onset of a rash on theskin, wipe the area of the rash on the skin with the body wipe 200carrying the copper ion-containing solution to deposit a liberal amountof the copper ion-containing solution on the rash. Allow the area of theskin to air dry. Repeat every four hours until the rash has disappeared.

The method of Example 40 involves applying a copper ion treatment in theform of a copper Ion cream, gel, lotion or foam to a rash on the skin,where the copper ion cream, gel, lotion or foam contains an amount ofthe copper ion-containing solution in the range of 5 percent to 30percent of the total weight of the copper ion cream, gel lotion or foam.The method of Example 40 may be carried out using the device 50 todispense the copper ion creams and gels, the device 60 to dispense thecopper ion lotion, and the device 70 to dispense the copper ion foam.The copper ion cream, gel, lotion or foam can be dispensed from thecorresponding device directly onto the area of the rash but, moretypically, the copper ion cream, get, lotion or foam will be dispensedfrom the corresponding device onto the hand and applied to the area ofthe rash using the fingers and hand as pointed out above.

Example 40

As soon as possible following diagnosis or the onset of a rash on theskin, liberally apply the copper ion treatment in the form of copper ioncream, gel, lotion or foam to the area of the rash on the skin. Gentlypat, rub or smooth the copper ion treatment into the area of the rash onthe skin. Repeat every four hours until the rash has disappeared.

An additional aspect of the invention pertains to treating cold sores orfever blisters on the skin, and particularly cold sores or feverblisters on the lips. Example 41 describes a method for treating coldsores (fever blisters) using a copper ion treatment in the form ofcopper ion cream, lotion or gel containing an amount of the copperion-containing solution in the range of 5 percent to 30 percent byweight of the total weight of the copper ion cream, lotion or gel. Incarrying out the method of Example 41, the copper ion cream, lotion orgel will be deposited onto the tip of a finger which is then used toapply the copper ion cream, lotion or gel to the cold sore. The methodof Example 41 is beneficial for treating cold sores caused by the herpesvirus (I and II) on account of the anti-viral effects that result fromthe copper ions coming into contact with the anatomical tissue affectedby the cold sore.

Example 41

As soon as possible following the first symptom of a cold sore, apply aliberal amount of copper ion treatment in the form of copper ion cream,lotion or gel to the cold sore. Gently pat rub or smooth the copper iontreatment into the cold sore. Repeat every four hours until the coldsore has disappeared.

It is also an aspect of the invention to use the copper ion treatmentsas cosmetic treatments on the skin as represented by the method ofExample 42. According to this aspect of the invention, the therapeuticeffects provided when the copper ions in the copper ion treatmentcontact the skin result in improved appearance of skin affected bywrinkles, sagging skin, undesirable pigmentation, age spots, dry skin,loss of collagen and loss of skin tone. The method of Example 42 maybest be carried out using the fingers to apply to the skin a copper iontreatment in the form of a copper ion cream or lotion. Also, copper iongels could be used, particularly gels of thin consistency in the form ofserums. The copper ion cream, lotion or gel contains an amount of thecopper ion-containing solution in the range of 5 percent to 30 percentof the total weight of the copper Ion cream, lotion or gel.

Example 42

Apply a liberal amount of a copper ion treatment in the form of copperion cream, lotion or gel to the skin on the face. Gently rub, pat orsmooth the copper ion treatment into the skin. Repeat the application ofthe copper ion treatment such that the copper ion treatment is appliedto the facial skin two times each day on a daily basis.

The method of Example 42 can be modified to include application of thecopper ion treatment to the skin on the neck. The method of Example 42can be carried out by applying the copper ion treatment to the skin oncein the morning and once in the evening every day on a regular basis.Preferably, the copper ion treatment should be applied to clean, dryskin for maximum effectiveness.

An additional aspect of the invention is represented by Example 43,which pertains to a method of treating “athlete's foot”, a commoninfection that appears on the feet. The method of Example 43 may best becarried out using the fingers and one or more hands to apply to anaffected foot a copper ion treatment in the form of a copper ion creamor lotion containing an amount of the copper ion-containing solution inthe range of 5 percent to 30 percent of the total weight of the copperion cream or lotion.

Example 43

As soon as possible following diagnosis or the first symptoms ofathlete's foot, apply a liberal amount of a copper ion treatment in theform of copper ion cream or lotion to the affected area of the foot. Rubthe copper ion treatment into the affected area. Apply the copper iontreatment to the opposite foot in the same manner if the opposite footis also affected by athlete's foot. Repeat the application of the copperion treatment to the one or both affected feet such that the copper iontreatment is applied twice a day to the one or both affected feet and iscontinued every day until the athlete's foot is resolved.

It is preferred that the method of Example 43 be carried out by applyingthe copper ion treatment to the one or both affected feet in the morningand in the evening each day. In addition, it is helpful if a clean whitesock is worn on the one or both affected feet following the applicationof the copper ion treatment in the morning.

The copper ion treatments can also be used to sanitize areas of theskin, particularly the hands. The antiseptic, antibacterial, antiviral,antifungal, anti-pathogenic, antimicrobial and anti-inflammatory effectsrealized as a result of the copper ions contacting the skin when thecopper ion treatments are applied thereto make the copper ion treatmentsparticularly well-suited for use as skin and hand sanitizers. Example 44describes a method of sanitizing an area of the skin using a copper iontreatment in the form of the copper ion-containing solution or in theform of copper ion lotion, gel or foam containing an amount of thecopper ion-containing solution in the range of 6 percent to 30 percentof the total weight of the copper ion lotion, gel or foam. The method ofExample 44 can be carried out by spraying the copper ion-containingsolution on the area of the skin to be sanitized, dispensing the copperion lotion, gel or foam directly on the skin or on the fingers or handwhich are then used to apply the copper ion lotion, gel or foam to thearea of the skin to be sanitized, or by using the body wipe 200 to applythe copper ion-containing solution to the skin.

Example 44

Apply a copper ion treatment in the form of a copper ion-containingsolution, a copper ion lotion, a copper ion gel or a copper ion foam tothe area of the skin to be sanitized. Gently rub or spread the copperion treatment on the area of the skin. Allow the area of the skin to airdry. Repeat the process as desired to sanitize the area of the skin.

A further aspect of the invention involves treating nail fungus usingthe copper ion treatments as represented by the method set forth inExample 45. The method of Example 45 may best be carried out using acopper ion cream containing an amount of copper ion-containing solutionin the range of 5 percent to 30 percent of the total weight of thecopper ion cream. However, it should be appreciated that other forms ofthe copper ion treatment could be used. When using a copper ion cream tocarry out the method of Example 45. the cream will normally be appliedby hand to a nail affected by a fungal condition and the fingers of thehand will be used to rub the cream into and around the affected nail.Depending on the form of copper ion treatment used, however, it shouldbe appreciated that the copper ion treatment could be applied to theaffected nail using the brush 45 of the device 40 depicted in FIG. 4 orthe swab 105 of the device 101 depicted in FIG. 11 , for example.

Example 45

As soon as possible following the first sign of a fungal condition in atoenail or fingernail, apply a liberal amount of a copper ion treatmentin the form of a copper ion cream to the affected nail. Using thefingers, thoroughly rub the copper ion cream into and around theaffected nail. Repeat the application such that the copper ion treatmentis applied to the affected nail twice a day for each day until the nailfungus has disappeared.

The copper ion treatments can be used on the skin or nails as atreatment for active or existing infections, diseases, inflammation orundesired body conditions or as a treatment to prevent the developmentof infections, diseases, inflammation and undesired body conditions. Thediseases or conditions affecting the dermatological areas that aretreatable with the copper ion treatments include one or more ofbacterial infections caused by staphylococcus, streptococcus,enterobacter, E. coli and pseudomonas, viral infections caused byshingles, herpes (I and II) and HPV, fungal infections such as athlete'sfoot, ringworm and fungus affecting the toenails or fingernails,impetigo, rosacea, psoriasis, eczema, warts, sunburn, windburn, dryskin, age spots, pigmentation, scarring, blisters, boils, cysts,pimples, cuts, scratches, incisions, burns, abrasions, splinters, insectbites and stings, animal bites and scratches, ulcers, particularlyulcers of the legs and feet, loss of elasticity or collagen, wrinkles,sagging skin, acne, measles, chicken pox, and the presence of pathogensand microbes on the skin.

Inasmuch as the present invention is subject to many variations,modifications and changes in detail it is intended that all subjectmatter discussed above or shown in the accompanying drawings beinterpreted as illustrative only and not be taken in a limiting sense.

The invention claimed is:
 1. A method of treating a bacterial infectioncaused by gonorrhea, the method comprising administering a copper ionsuspension to a subject in need thereof, wherein the copper ionsuspension consists of: copper ions; a saline solution; and one or morebuffers; wherein the copper ions are leached into a first solution froma solid copper metal by: (a) placing the solid copper metal in the firstsolution consisting of the saline solution and the one or more buffers;(b) allowing the solid copper metal to remain in the first solution fora predetermined period of time, during which predetermined period oftime the solid copper metal leaches into the first solution; and (c)removing the solid copper metal from the first solution after thepredetermined period of time.
 2. The method of claim 1, wherein thebacterial infection caused by gonorrhea affects anatomical tissue of thesubject in need thereof, and wherein the copper ion suspension isapplied such that the copper ions of the copper ion suspension contactthe anatomical tissue affected by the bacterial infection caused bygonorrhea.
 3. The method of claim 1, wherein the method comprisespreventing of biofilm formation caused by the bacterial infection causedby gonorrhea.
 4. The method of claim 1, wherein the copper ionsuspension is disposed in a second solution, a cream, a lotion, a gel, afoam, a paste, a spray, or a suppository.
 5. The method of claim 4,wherein the cream, gel, lotion, paste, spray, or suppository contains anamount of the copper ion suspension in the range of 5 percent to 30percent of the total weight of the second solution, the cream, thelotion, the gel, the foam, the paste, the spray, or the suppository. 6.The method of claim 1, wherein the solid copper metal consists of a purecopper.
 7. The method of claim 1, wherein the solid copper metalconsists of a copper alloy.
 8. The method of claim 7, wherein the copperalloy is selected from the group consisting of a brass, a bronze, acopper-nickel alloy, and a copper-zinc alloy.
 9. A method of treating abacterial infection caused by gonorrhea, the method comprising: (a)making a copper ion suspension, wherein making the copper ion suspensioncomprises the steps of: (i) placing a solid copper metal in a solutioncomprising saline and a buffer; (ii) allowing the solid copper metal toremain in the solution for a predetermined period of time, during whichpredetermined period of time the solid copper metal leaches into thesolution; and (iii) removing the solid copper metal from the solutionafter the predetermined period of time; wherein the copper ionsuspension comprises: copper ions, and the solution comprising salineand the buffer, and (b) administering the copper ion suspension.
 10. Themethod of claim 9, wherein the bacterial infection caused by gonorrheaaffects anatomical tissue of the subject in need thereof, and whereinthe copper ion suspension is applied such that the copper ions of thecopper ion suspension contact the anatomical tissue affected by thebacterial infection caused by gonorrhea.
 11. The method of claim 9,wherein the method comprises preventing of biofilm formation caused bythe bacterial infection caused by gonorrhea.
 12. The method of claim 9,wherein the copper ion suspension is disposed in a second solution, acream, a lotion, a gel, a foam, a paste, a spray, or a suppository. 13.The method of claim 12, wherein the cream, gel, lotion, paste, spray, orsuppository contains an amount of the copper ion suspension in the rangeof 5 percent to 30 percent of the total weight of the second solution,the cream, the lotion, the gel, the foam, the paste, the spray, or thesuppository.
 14. The method of claim 9, wherein the solid copper metalconsists of a pure copper.
 15. The method of claim 9, wherein the solidcopper metal consists of a copper alloy.
 16. The method of claim 15,wherein the copper alloy is selected from the group consisting of abrass, a bronze, a copper-nickel alloy, and a copper-zinc alloy.